advanced tumor with lung metastases
Conditions
Interventions
Experimental group:inhalation of homoharringtonine+PD-1 monoclonal antibody
Sponsors
Clifford Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 60 years (including the boundary value); 2. Histologically or cytologically confirmed advanced malignant tumor, with multiple lung metastases, and standard treatment fails or lacks effective treatment methods; 3. At the time of enrollment, the ECOG performance status score was 0 or 1; 4. Expected survival period >= 3 months; 5. There are more than 3 lung lesions, and the diameter of a single lesion is less than or equal to 2cm. 6. The functional level of vital organs before the first use of the study drug must meet the following requirements (any blood components, cell growth factors, whitening drugs, platelet-raising drugs, etc. are not allowed to be used within 7 days before obtaining the laboratory test): (1) The absolute count of neutrophils is >=1.5x10^9/L. (2) Platelets>=100x10^9/L. (3) Hemoglobin >=90 g/L. (4) Serum albumin >= 30 g/L. (5) AST and ALT1.5×ULN, the creatinine clearance rate (CLcr) calculated by the Cockcroft-Gault equation is >=30 mL/min. (8) Cardiac left ventricular ejection fraction (LVEF) > 50%. (9) Pulmonary function test: (1) Ventilation function indicators, including forced vital capacity (FVC) normal range: male 3.179+0.117L female 2.314+0.048L; forced expiratory volume in one second (forced expiratory volume in one) second, FEV1)>80%. (2) The normal range of maximal voluntary ventilation (MVV): male 104+2.71L; female 82.5+2.17L.
Exclusion criteria
Exclusion criteria: 1. Pregnancy, breastfeeding women, or women of childbearing age who have a positive result of blood and/or urine pregnancy test before the trial; male and female subjects have not taken effective contraceptive measures, or plan to perform pregnancy or impregnation within 3 months after the start of the trial; 2. The subject suffers from mental disability or severe emotional or mental disorder, and the researcher believes it is not suitable for inclusion in this study; 3. The subject has a symptomatic primary or metastatic central nervous system malignant tumor; 4. The subject has received other clinical research study drugs within 4 weeks before screening; 5. The subject has an allergic reaction to the components of homoharringtonine injection; 6. The subject has any situation that the researcher thinks is not suitable for participating in this research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate,ORR;tolerability; | — |
Countries
China
Contacts
Public ContactCai Qichun
Clifford Hospital
Outcome results
None listed